METHODS: A systematic review and Delphi consensus panel (consisting of eight8 international pediatric allergists and gastroenterologists) was conducted to evaluate evidence supporting growth, tolerability, and effectiveness of pHF in non-exclusively breastfed infants.
RESULTS: None of the studies reviewed identified potential harm of pHF use compared with CMP in non-exclusively breastfed infants. There was an expert consensus that pHF use is likely as safe as intact CMP formula, given studies suggesting these have comparable nutritional parameters. No high-quality studies were identified evaluating the use of pHF to prevent allergic disease in non-exclusively breastfed infants who are not at risk for allergic disease (e.g., lacking a parental history of allergy). Limited data suggest that pHF use in non-exclusively breastfed infants may be associated with improved gastric emptying, decreased colic incidence, and other common functional gastrointestinal symptoms compared with CMP. However, because the data are of insufficient quality, the findings from these studies have to be taken with caution. No studies were identified that directly compared the different types of pHF, but there was an expert consensus that growth, allergenicity, tolerability, effectiveness, and clinical role among such pHF products may differ.
CONCLUSIONS: Limited data exist evaluating routine use of pHFs in non-exclusively breastfed infants, with no contraindications identified in the systematic review. An expert consensus considers pHFs for which data were available to be as safe as CMP formula as growth is normal. The preventive effect on allergy of pHF in infants who are not at risk for allergic disease has been poorly studied. Cost of pHF versus starter formula with intact protein differs from country to country. However, further studies in larger populations are needed to clinically confirm the benefits of routine use of pHF in non-exclusively breastfed infants. These studies should also address potential consumer preference bias.
METHODS AND ANALYSIS: The target participants are infants born from January to June 2015 in the South East Asia Community Observatory (SEACO) platform. The SEACO is a Health and Demographic Surveillance System (HDSS) that is established in the District of Segamat in the state of Johor, Malaysia. For the quantitative strand, the sociodemographic data, feeding practices, anthropometry measurement and total nutrient intake will be assessed. The assessment will occur around the time complementary feeding is expected to start (7 Months) and again at 12 months. A 24-hour diet recall and a 2-day food diary will be used to assess the food intake. For the qualitative strand, selected mothers will be interviewed to explore their infant feeding practices and factors that influence their practices and food choices in detail.
ETHICS AND DISSEMINATION: Ethical clearance for this study was sought through the Monash University Human Research and Ethics Committee (application number CF14/3850-2014002010). Subsequently, the findings of this study will be disseminated through peer-reviewed journals, national and international conferences.